Medical Design Briefs - September 2022 - 31

Risk Management for Cybersecure Networked
Medical Devices
Comprehensive and
complete security risk
management helps
develop efficient
countermeasures.
TÜV SÜD Product Service
Munich, Germany
For developers and manufacturers of
networked medical devices, IT security is
increasingly becoming a challenge. While
the number of cyber threats is growing significantly,
companies often lack experience
and clear guidelines for medical security. A
comprehensive and complete security risk
management plan helps to meet existing
requirements in the best possible way and
helps develop efficient countermeasures.
The healthcare sector is more in the
public eye than ever before during the
coronavirus pandemic. The sector has
been doubly affected: On the one hand,
intensive care had to be stretched to the
limit at times, and politicians and the media
everywhere are calling for medical and
epidemiological expertise. On the other
hand, cyber threats in the healthcare sector
increased massively. According to the
" 2021 Global Threat Intelligence Report "
of the technology service company NTT,
the number of cases in the healthcare sector
tripled in 2020 compared to the previous
year.1
Four out of five medical device
manufacturers were the target of at least
one attack in 2019. Telemedicine and remote
care were the most affected.
Nearly one in four medical devices is
connected to the Internet or otherwise
connected to a network. While there were
already around 337 million devices in 2017,
the number is estimated to rise to 125 billion
by 2030.2
This also includes digital
MDB Nelson Labs Ad 0622_ADAM.qxp_1/2 Page Horizontal 5/18/22 5:49 PM Page 1
health applications, whose development is
encouraged by several European initiatives
like the German " Digital Healthcare Act. " 3
In times of pandemic, when care should be
as contactless as possible, they receive special
attention.
n Little Experience and Serious
Consequences
The attacks range from extortion attempts
(ransomware) to industrial espionage.
Besides pharmaceutical companies
and clinics, research institutions are also
targeted. In the worst case, manipulations
in sensitive medical areas endanger the
safety of patients and users. However, the
affected manufacturers and institutions
must also reckon with considerable and
lasting economic consequences in less serious
cases - for example, due to the loss of
brand image if critical security vulnerabilities
or safety deficits become public.
A secure product requires effective security
measures and a clear set of requirements.
However, many manufacturers
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Medical Design Briefs - September 2022

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Medical Design Briefs - September 2022 - Cov1A
Medical Design Briefs - September 2022 - Cov1B
Medical Design Briefs - September 2022 - Cov1
Medical Design Briefs - September 2022 - Cov2
Medical Design Briefs - September 2022 - 1
Medical Design Briefs - September 2022 - 2
Medical Design Briefs - September 2022 - 3
Medical Design Briefs - September 2022 - 4
Medical Design Briefs - September 2022 - 5
Medical Design Briefs - September 2022 - 6
Medical Design Briefs - September 2022 - 7
Medical Design Briefs - September 2022 - 8
Medical Design Briefs - September 2022 - 9
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Medical Design Briefs - September 2022 - Cov3
Medical Design Briefs - September 2022 - Cov4
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